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QA Operations Associate

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -022020-26369 Region: Edison-New Brunswick Metro Area

Job Description

Duties:

Creation and issuance of Batch Records for execution in Operations. Printing and issuance of labels to support Manufacturing Operations.

Issuance of final product labelling. Entering/maintaining information accurately in systems/applications (e.g. SAP, LIMS, Cell Chain, etc.) as necessary to support operations and overall life cycle of documents.


Skills:

Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, automation, validation, etc.) preferred. Experience in Quality Assurance, Batch Record Issuance, Batch Record Verification, Label Issuance, and Batch Record Review. Continuous improvement mindset. Enjoys working as a team member as well as independently. Ability to communicate openly and effectively written and verbal in an engaging manner with colleagues of various levels of experience and management. Comfortable working in a matrix environment and communicating with site and possible other global positions.


Education:

(Technical) University/academy degree in Biological Sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.

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